MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-03-18 for STERI-STRIP WOUND CLOSURES UNKNOWN manufactured by 3m Health Care.
[1289906]
The patient has prostatic robotic surgery and was admitted. Blisters around his lap sites although his incision sites were ok. The blisters became worse after discharge requiring a visit to the surgeon's office to have them drained. The patient returned for another procedure the following week with concerns regarding what may have caused the blisters. The surgeon's office stated they believed the blisters were an allergic reaction to the steri-strips. The patient will list steri-strips as an allergy in the future.
Patient Sequence No: 1, Text Type: D, B5
[8544501]
Product labeling states the expected aes with product use in the warning section shown below. Warnings: the development of postoperative edema may cause skin shearing, skin blistering, or loss of tape adhesion to occur at either end of the strip. Application of any surgical tape or adhesive skin closure may result in skin stripping upon removal. As with all adhesive products applied to the skin, a small percentage of individuals may experience hypopigmentation or hyperpigmentation following removal. Occasional cases of mild acne and folliculitis have been observed in testing on healthy volunteers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2010-00028 |
| MDR Report Key | 1640034 |
| Report Source | 05 |
| Date Received | 2010-03-18 |
| Date of Report | 2010-02-22 |
| Date of Event | 2010-01-19 |
| Date Mfgr Received | 2010-02-22 |
| Date Added to Maude | 2010-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KAREN RITTLE, MANAGER |
| Manufacturer Street | 275-5W-06 |
| Manufacturer City | SAINT PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517330074 |
| Manufacturer G1 | 3M HEALTH CARE PLANT - BROOKINGS |
| Manufacturer City | BROOKINGS SD |
| Manufacturer Country | US |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERI-STRIP WOUND CLOSURES |
| Generic Name | TAPE, SKIN CLOSURE |
| Product Code | FPX |
| Date Received | 2010-03-18 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | SAINT PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-03-18 |